A Prospective, Open Label Study Evaluating the Efficacy of Two Management Strategies (Pantoprazole 40 mg q.a.m. and Taking Pradaxa® With Food (Within 30 Minutes After a Meal) on Gastrointestinal Symptoms (GIS) in Patients Newly on Treatment With Pradaxa® 150 mg b.i.d., 110 mg b.i.d. or 75 mg b.i.d. for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation (NVAF)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,067
- 试验地点
- 103
- 主要终点
- The Rate of Complete Effectiveness of Initial GIS Management Strategy
研究概览
简要总结
This is a prospective and open label study that aims to enroll approximately 1200 patients with non-valvular atrial fibrillation (NVAF) not previously treated with Pradaxa® and free of gastrointestinal symptoms (GIS) for at least 2 weeks prior to enrolment. Approximately 125 sites in North America will be recruited. Patients who report GIS during the 3 month treatment period will be randomized to one of two management strategies, and data documenting the intensity and duration of the GIS will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Pradaxa (dabigaran etexilate)
Patients with non valvular atrial fibrillation for whom Pradaxa is indicated in accordance with the current local label, not previously treated with Pradaxa, will be provided 3 months of treatment for the prevention of stroke and systemic embolism. Patients who report gastrointestinal symptoms (GIS) will be randomized to one of two management strategies, and data documenting the intensity and duration of the GIS will be collected.
干预措施: Pradaxa (dabigatran etexilate) (Drug)
Pradaxa and pantoprazole
Patients that develop gastrointestinal symptoms (GIS) will be randomized 1:1 to either pantoprazole 40 mg q.a.m., p.o., or taking Pradaxa (dabigatran etexilate) within 30 minutes after a meal
干预措施: pantoprazole (Drug)
Pradaxa and pantoprazole
Patients that develop gastrointestinal symptoms (GIS) will be randomized 1:1 to either pantoprazole 40 mg q.a.m., p.o., or taking Pradaxa (dabigatran etexilate) within 30 minutes after a meal
干预措施: Pradaxa (dabigatran etexilate) (Drug)
Pradaxa, 30 minutes after a meal
Patients that develop gastrointestinal symptoms (GIS) will be randomized 1:1 to either pantoprazole 40 mg q.a.m., p.o., or taking Pradaxa (dabigatran etexilate) within 30 minutes after a meal
干预措施: Pradaxa, within 30 minutes after a meal (Drug)
结局指标
主要结局
The Rate of Complete Effectiveness of Initial GIS Management Strategy
时间窗: Week 4
The percentage of patients experiencing complete relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks. Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved.
次要结局
- Rate of Complete Effectiveness of Combined GIS Management Strategies(Week 8)
- Time Between Symptom Onset and First Observed Complete or Partial Effectiveness and Between Symptom Onset and Last Observed Symptom(Week 8)
- Rate of Partial Effectiveness of Initial GIS Management Strategies(Week 4)
- Rates of Partial Effectiveness of GIS at Each Visit.(Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8)
- Combined Rate of Complete or Partial Effectiveness of Combined GIS Management Strategies(Week 8)
- Combined Rate of Complete or Partial Effectiveness of Initial GIS Management Strategies(Week 4)
- Rates of Complete Effectiveness of GIS at Each Visit.(Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8)
- Rates of Complete or Partial Effectiveness of GIS at Each Visit.(Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8)
- Rate of Partial Effectiveness of Combined GIS Management Strategies(Week 8)